Altamira Therapeutics Announces Certification of Bentrio Nasal Spray under Medical Device Regulation
Rhea-AI Summary
Altamira Therapeutics (OTCQB:CYTOF) announced on November 20, 2025 that associate Altamira Medica obtained EU Medical Device Regulation (MDR) certification for Bentrio nasal spray. The certification confirms conformity with the EU's stricter safety, performance and quality requirements for medical devices and is a prerequisite for legally commercializing Bentrio in EU member states.
The announcement notes Bentrio was previously launched under the MDD as a Class I device in 2021 and was up‑classified to Class IIa under MDR, which required clinical trials, independent Notified Body certification and substantial investments by Medica. The company says MDR status also supports regulatory filings outside the EU and aids the product's international growth strategy.
Positive
- MDR certification obtained for Bentrio on November 20, 2025
- Enables commercialization of Bentrio in EU member states
- Supports international filings as MDR serves as external reference
- Clinical trials completed to meet MDR Class IIa requirements
Negative
- Up‑classification to Class IIa increased regulatory requirements
- Substantial efforts and investments required to achieve MDR compliance
News Market Reaction 1 Alert
On the day this news was published, CYTOF declined 21.11%, reflecting a significant negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
Conformity with stringent new EU regulations for medical devices confirmed
Allows for commercialization of Bentrio in EU member states; facilitates regulatory approval in various other countries
Major milestone in international growth strategy
HAMILTON, BERMUDA / ACCESS Newswire / November 20, 2025 / Altamira Therapeutics Ltd. ("Altamira" or the "Company") (OTCQB:CYTOF), a company dedicated to developing and supplying nucleic acid delivery technology for partners in biotech and pharma, today announced that its associate company Altamira Medica ("Medica") obtained certification of its Bentrio® nasal spray under the European Union's Medical Device Regulation (MDR). Bentrio is a drug-free, preservative-free nasal spray for protection against airborne allergens which is commercialized by Medica through a network of marketing and distribution partners.
"The MDR certification represents a major milestone for our innovative Bentrio nasal spray as it is a prerequisite for commercializing the product in the European Union and beyond," commented Thomas Meyer, Medica's Chairman and CEO. "The certification declares Bentrio's conformity with the EU's new rigorous requirements for demonstrating and ensuring the safety, performance and quality of medical devices. Further, it serves as a key reference for certain regulatory agencies outside the EU, thus facilitating marketing clearance in various countries. We look forward to moving forward with our growth strategy with Bentrio in close collaboration with our international marketing and distribution partners."
The EU started to implement the MDR framework in 2021, thus gradually replacing the Medical Device Directive (MDD). Bentrio was launched in certain EU markets in 2021 as a "Class I" medical device under MDD, based on a self-declaration of conformity. Under MDR, nasal sprays such as Bentrio are considered "Class IIa" medical devices, implying additional regulatory requirements. The new regulations, together with the up-classification, required substantial efforts and investments by Medica, including the conduct of clinical trials and independent certification by a designated Notified Body.
About Bentrio
Bentrio is an "over the counter" drug-free nasal spray for personal protection against airborne allergens and, where approved, against airborne viruses. Upon application into the nose, Bentrio forms a protective gel layer on the nasal mucosa. This thin film is designed to prevent the contact of airborne particles with cells; in addition, the composition serves to bind such particles and help with their discharge. The efficacy and safety of Bentrio have been demonstrated in a total of four clinical trials, of which the largest one ("NASAR" study) enrolled 100 patients suffering from seasonal allergic rhinitis. In NASAR, participants self-administered either Bentrio or saline nasal spray for two weeks 3 times per day. The study showed a statistically significant reduction in the mean daily reflective Total Nasal Symptom Score (rTNSS) for Bentrio compared to saline (p = 0.013), as well as a statistically highly significant improvement in health-related quality of life (Rhinoconjunctivitis Quality of Life Questionnaire, p < 0.001) and superior global ratings of efficacy by patients and investigators alike (p < 0.001). In addition, Bentrio showed good safety and tolerability, similar to saline controls, and fewer Bentrio treated patients used relief medication and more of them enjoyed symptom-free days compared to saline treatment. For more information, visit: www.bentrio.com
About Altamira Therapeutics
Altamira Therapeutics is developing and supplying peptide-based nanoparticle technologies for efficient nucleic acid delivery (xPhore™ platform). The versatile delivery platform is suited for different nucleic acid modalities, including siRNA, mRNA, circRNA, as well as DNA, and made available to pharma or biotech companies through out-licensing. The Company has two proprietary flagship programs based on xPhore and siRNA payloads: AM-401 for KRAS driven cancer and AM-411 for rheumatoid arthritis, both in preclinical development beyond in vivo proof of concept. In addition, Altamira holds a
Forward-Looking Statements
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SOURCE: Altamira Therapeutics Ltd.
View the original press release on ACCESS Newswire
FAQ
What does Altamira Therapeutics (CYTOF) announce on November 20, 2025 about Bentrio?
How does MDR certification affect Bentrio's ability to sell in EU markets?
Why was Bentrio reclassified to Class IIa under MDR and what did that require?
Will the MDR certification help Bentrio gain approval outside the EU?
What investor implications does the Bentrio MDR certification have for CYTOF shareholders?
When was Bentrio originally launched in EU markets and under which directive?
